In the field of medical surgeries, many devices control and stop bleeding by putting pressure on the internal tissue of the body from the zone of the perforation in blood vessels. Several diagnostic and interventional procedures can be mentioned, such as coronary artery angiography and angioplasty, renal, carotid, organs, central venous angiography and angioplasty, etc. In these actions, there is a need for vascular access in many cases. The treatment is carried out with a diagnostic device by inserting cannula-like instruments, sometimes with a relatively large diameter. After the intravascular procedure, the cannula-like instruments must be taken out and the arterial puncture must be blocked to prevent bleeding.
Generally, coronary artery angiography is done through femoral artery in groin area by placing arterial sheath with different diameters. After angiography, arterial sheath must be removed from the artery; therefore, it is required to block the perforation in the blood vessel wall to stop the bleeding. Traditionally, a trained medical person puts pressure by hands on the tissue between the skin and the vessel wall at the zone of the puncture from the skin for approximately 20 minutes or more until the bleeding is stopped fully in the puncture created in the blood vessel. This process is difficult and exhausting for both health care workers and the patient. After the initial hemostasis, the zone of puncture is dressed, and then a three to five-kilogram sandbag is placed on the zone of the puncture for 6 hours. This method is still used in most medical centers. In this method, sanitation as well as infection and safety controls of both patients and health care workers using the sandbag are not sometimes observed appropriately and mistakes can happen. The major set of problems encountered in such a method is the use of multiple weights, pain in the lower back and groin area of the patient, difficulty with placement and the stability of the sandbag, mobility restrictions for the patient for a long time, and the lack of direct visibility of the hemostasis area.
Another method is using a metal device which consists of a metal plate placed under the groin of the patient and a vertical stand fixed at the end of the metal plate. The assembly is L-shaped and fixed, and placed on the vertical stand of another stand which is movable. The final component is a movable protuberance which transfers rotary press of the final component to the zone of the puncture. In this case, it is difficult to adjust the location of the compression zone and there is the possibility of relocation and partial obstruction of the arteries with the movement of the patient's femur and pelvis muscles. The pressure is reasonably high, intolerable and long for the patient.
Another method is using a balloon-like device at the zone of the puncture placed on the skin. The balloon-like device is fixed on the groin by long adhesive fins in the shape of a cross. Air or liquid is injected to the balloon bag through a pipe attached to the balloon which generates pressure at the blood vessel perforation. This device can be used after initial hemostasis. However, when the patient retracts his legs, the pressure which is put on the area is reduced and thus the possibility of bleeding and hematoma will be increased. Yet another method is using angio-seal device. In this method, the device stitches the arterial wall perforation which eventually leads to vessel hemostasis. However, in this method, there is the possibility of blood leakage from the stitches. Narrowing the blood vessel is also a probability with this method, and the blockage of a blood vessel or its lateral branches is possible.
Another method is using a Vaso-Seal device. In this method, a gelatinous substance is injected on the arterial wall perforation to create pressure by the support of surrounding tissues for hemostasis. But, in this method, there is the possibility of not creating an optimum pressure on the arterial perforation, and too much pressure may cause the probability of permeation of the gelatinous substance into the vein and the possibility of narrowing the blood vessel as well as thrombosis or occlusion. Thus, there are major problems during the usage of the prior art devices to enable hemostasis in skin puncture and femoral artery puncture. In venipuncture stages, artery perforation may be formed by angiographic needle at several points, the exact location of the blood vessel perforation may not be recognizable due to the angle of needle insertion into the skin and passing through different tissues between the skin and blood vessel in lean or obese patients.
Considering all the above-mentioned requirements, there is a need for a device which can create more comfort and less pain in the groin area or lower back of the patients, reduce vascular complications, create better mobility for patients, prevent the transmission of infection and providing more safety for the patient and healthcare workers, prevent trained medical staff fatigue as well as the waste of their time and energy. Further, there is a need for a device which can provide better control in treatment stages of the patients, and to avoid pressure fluctuations in the zone of femoral artery hemostasis because pressure fluctuations in the zone of the puncture can cause subcutaneous hemorrhage or hematoma in the zone of the puncture. In addition, in the case of the infection of sandbags made of fabric or artificial leather, the risk of the transmission of nosocomial infections to other patients or healthcare workers can be increased since it's impossible to clean. When the sand and soil pour out from the sandbag steadily, the contamination of angiography room will be also possible. So, the anticipated device should avoid such contaminations and infections which could be caused by use of conventional exiting devices and methods.